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Document: spc-doc_PL 41318-0039 change

• spc-doc_PL 00531-5127R
• spc-doc_PL 12965-0035
• spc-doc_PL 28444-0136
• spc-doc_PL 41318-0039

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SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Surgical Spirit BP.

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Methyl salicylate BP 0.5% v/v.

3    PHARMACEUTICAL FORM

Topical solution.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Used as an antiseptic for cleaning the skin and for general sickroom purposes. Intended for topical administration to human beings and as a general disinfectant.

4.2    Posology and method of administration

For children and adults, including the elderly.

4.3    Contraindications

Hypersensitivity to the actives and any of the excipients On mucous membranes and excoriated skin surface.

4.4    Special warnings and precautions for use

For external use only. Caution: flammable. Keep away from naked flames.

4.5    Interaction with other medicinal products and other forms of interaction

None stated.

4.6    Pregnancy and lactation

Acceptable for use during pregnancy and lactation.

4.7    Effects on ability to drive and use machines

None stated.

4.8    Undesirable effects

None stated.

4.9    Overdose

Overdose from methyl salicylate occurs when someone accidentally or intentionally use the product orally. This may result in the development of nausea, vomiting, agitation, difficulty in breathing, dizziness and ringing in the ears, fever, acid-base disturbance etc. Also, it can cause severe, rapid-onset salicylate poisoning because of its liquid concentrated form and lipid solubility.

The management includes supportive measures, activated charcoal, IV fluids, and sodium bicarbonate.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

This product acts as an astringent.

5.2    Pharmacokinetic properties

The product contracts the skin and thus stops seepage of fluid. The alcohol is lostmainly by evaporation, the other ingredients are absorbed by the skin and excreted in the urine.

5.3    Preclinical safety data

Not applicable.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Castor oil Diethyl phthalate Industrial methylated spirit

6.2    Incompatibilities

None stated.

6.3    Shelf life

3 years.

6.4    Special precautions for storage

Keep away from naked flame.

6.5    Nature and contents of container

Amber glass bottle with plastic caps: l00ml, 200ml, 250ml, 500ml, 2000ml. Plastic container with plastic cap: 2000ml